{"id":11308,"date":"2020-01-30T10:38:27","date_gmt":"2020-01-30T09:38:27","guid":{"rendered":"https:\/\/saludporderecho.org\/?p=11308"},"modified":"2020-01-30T10:38:29","modified_gmt":"2020-01-30T09:38:29","slug":"a-great-victory-for-transparency","status":"publish","type":"post","link":"https:\/\/saludporderecho.org\/en\/a-great-victory-for-transparency\/","title":{"rendered":"A great victory for transparency"},"content":{"rendered":"\n

Last week, the Court of Justice of the European Union ruled in favour of the right of third parties to be able to access the reports on clinical studies that the pharmaceutical industry carries out for the approval of medicines in the European Union. <\/strong><\/p>\n\n\n\n

In 2018, pharmaceutical company PTC\nTherapeutics took the European Medicines Agency (EMA) to court after it had\ngranted third parties access to clinical study reports that the pharmaceutical\ncompany had submitted to the Agency in the process of obtaining authorisation\nfor placing one of its medicines on the market. <\/p>\n\n\n\n

The company argued in its appeal that\nclinical study reports (CSRs) should remain fully confidential so as not to\ndamage commercial interests. In their defence, the EMA – which before granting\naccess to the information had redacted certain passages that were considered\nconfidential – argued that the remaining and accessible information in the\nreports was not confidential nor could it prejudice the company’s interests.  <\/p>\n\n\n\n

On 22 January, the Court of Justice of the\nEuropean Union rejected the appeal presented by TPC with an historic ruling in\nfavour of the EMA, after confirming that said reports have no presumption of\nconfidentiality and that it considered the existence of a risk misuse of the\ndata which could undermine the commercial interest of the company not to have\nbeen demonstrated. <\/p>\n\n\n\n

The Judgement represents a boost for the\nprogress in transparency made by the EMA over recent years after continued and\ngrowing calls from researchers, academics, civil society activists and even the\nEuropean Ombudsman. In fact, last year, after becoming aware of the appeal\nlodged by PTC Therapeutics International, over 44 organisations reminded\nthis body of the need to introduce greater transparency and access to clinical\nstudy reports<\/a>. <\/p>\n\n\n\n

This important step can help independent\nscientists to access detailed information in the design, development, findings\nand analysis of clinical studies including, for example, the data and effects,\nboth positive and negative, on patients. \u201cSeveral large-scale incidents of harm\nto patients in the recent past could have been averted if data contained in Clinical\nStudy Reports had been accessible at the time\u201d, assures\nTill Bruckner<\/a>, founder of the website TranspariMED.<\/p>\n\n\n\n

This historic ruling could mean a major\nadvance in transparency beyond Europe, as clinical study reports form part of a\nstandard format for requests for approval of medicines submitted by\npharmaceutical companies. These are documents which, traditionally, have\nremained confidential. In response to the ruling, the EMA declared, \u201cthe judges\nconfirmed that transparency must be the rule and exceptions must be applied and\nconstrued narrowly.\u201d <\/p>\n\n\n\n

Furthermore, the ruling may also constitute\na step forward in the implementation of transparency in other processes of the\nresearch, development and marketing chain of medicines, much of which remains\nopaque, allowing the pharmaceutical industry to place high prices on medicines.\nThis ruling is also encouraging looking to the\njudicial process in which we are present against Novartis<\/a> which,\nsince last year, is attempting to use the courts to avoid making public the\ntherapeutic and economic criteria on the basis of which the Ministry of Health\njustified the approval of Kymriah, an innovative treatment for a specific type\nof cancer the price of which was set at \u20ac350,000 per patient. <\/p>\n","protected":false},"excerpt":{"rendered":"

Last week, the Court of Justice of the European Union ruled in favour of the right of third parties to be able to access the reports on clinical studies that<\/p>\n","protected":false},"author":2,"featured_media":11296,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[309],"tags":[96,114],"class_list":["post-11308","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-home-slider-en","tag-espana","tag-precio-medicamentos"],"yoast_head":"\nA great victory for transparency | Salud por Derecho<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/saludporderecho.org\/en\/a-great-victory-for-transparency\/\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:title\" content=\"A great victory for transparency | Salud 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